Method and system for improving and assisting in medication compliance

ABSTRACT

A medication adherence system for facilitating adherence to a medication dosage schedule is provided, comprising a smart case to receive or adhere to a medication pack, a sensor for detecting a medication event, and a tangible computer readable medium interface for users to obtain feedback regarding their adherence to their respective medication dosage schedules.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/950,059, filed Apr. 10, 2018, which claims priority and otherbenefits from U.S. Provisional Patent Application Ser. No. 62/483,475,filed Apr. 10, 2017, the entire content of which is incorporated hereinby reference.

FIELD OF THE INVENTION

This invention relates generally to medical devices and moreparticularly to systems and methods for ensuring compliance by a patientin taking scheduled medications.

BACKGROUND OF THE INVENTION

One of the most significant problems that negatively impacts theeffectiveness of medications is poor patient adherence—in other words,patients' inability or unwillingness to take their medications asprescribed. For medications to work effectively, they must be taken atvery specific doses and time intervals. When patients deviate from theprescribed medication regimen, or fail to take a dose they often rendertheir medications less effective or completely ineffective and, evenworse, they may experience adverse effects from their improperly orirregularly used medications.

Healthcare providers and healthcare systems recognize the problem ofpoor medication adherence, but there is still enormous potential forimprovement. There is a need for systems to assist patients and users inmedication compliance by providing them with real-time, periodiccompliance or non-compliance indicators and signals through variousauditory, visual or other stimuli.

BRIEF SUMMARY OF THE INVENTION

The present application provides a smart case, which is a medicationcompliance device, for holding a medication pack having a plurality ofmedication dose holders each configured to hold a single medicationdose. The smart case is configured to wirelessly communicate with anexternal device to monitor compliance, send reminders, predicteffectiveness of the medication based on the actual dosing schedulerecorded by the system, and the like.

In a first aspect of the present invention, the smart case comprises abase shell for removably receiving a medication pack, a lid attached tothe shell and having a closed position where the medication pack iscovered and open position where the medication dose holders on themedication pack are accessible by a user, and a lid sensor configured todetect when the lid is moved between the closed position and the openposition. The smart case further includes circuitry comprising aprocessor and a wireless link, wherein the lid sensor is connected tothe circuitry a power source connected to the circuitry. The circuitryis configured to emit a signal via the wireless link to the externaldevice when the cover is opened.

In specific embodiments, the lid may be attached to the base by a hingeand the base may comprise a lid sensor that detects when the lid opens.In other embodiments, the lid may be slidably attached to the base andthe base comprises a lid sensor that detects when the lid is slid to anopen position. In still other embodiments, the smart case may furthercomprise a medication pack sensor which detects when the medication packis accessed from the smart case, wherein the lid sensor is connected tothe circuitry and the circuitry is configured to emit a signal via thewireless link to the external device each time a medication pack isaccessed. In still other embodiments, the smart case may furthercomprise a dose holder sensor which detects opening of a single doseholder, wherein the lid sensor is connected to the circuitry and thecircuitry is configured to emit a signal via the wireless link to theexternal device each time a dose holder is opened. The medication packsensor and dose holder sensor may comprise any one or more of a varietyof sensors, such as capacitive, resistive, electromagnetic (e.g., HallEffect), optical (e.g., infrared), inductive, mechanical switches,acoustic (e.g., microphones), or image processing sensors. The circuitrymay be configured to power the medication pack sensor or dose holdersensor only when the lid sensor indicated that the lid is open. In stillfurther embodiments, the smart case may further comprise a frameattached to the base for removably receiving the medication pack, andthe frame may be attached to the base by an attachment mechanism thatraises the frame and medication pack above an upper surface of the basewhen the lid is opened. For example, the attachment mechanism maycomprise a spring hinge.

In a second aspect of the present invention, a method for facilitatingcompliance with a medication dosage schedule comprises sensing, with aprocessor on a medication compliance device such as the smart casecoupled with a medication pack, when a user has interacted with themedication pack to gain access to individual medication holders on themedication pack. The processor on the medication compliance devicedetermines whether a medication pack has been accessed, or an individualmedication dose has been removed from an individual medication doseholder on the medication pack and transmits the time that either ofthese events occurred to an external device for recording or determiningcompliance with the medication dosage schedule. A user is determined tobe in compliance with the medication dosage schedule, if all medicationevents, i.e. consumption of medication doses, occurred in accordance toan indicated, recommended and/or preset schedule within a givenmedication window. A user is determined not to be in compliance with themedication dosage schedule, if one or more medication events did notoccur within a given medication window, as scheduled. If a user isdetermined not to be in compliance, feedback in form of various stimuliis provided to the user in order to inform the user and to encourageadherence to the medication dosage schedule. If the medication inquestion is an oral contraceptive pill, such feedback may includeinstructions on how to proceed if the user is determined not to be incompliance and if the user is at a certain risk of pregnancy.

In specific embodiments of such methods, sensing user interaction withthe medication pack is detected by a first sensor on the medicationcompliance device and sensing when the individual medication dose hasbeen removed from the individual medication dose holder on themedication pack is detected by a second sensor on the medicationcompliance device. The first sensor is typically active at all times,but the second sensor is energized to be in a sensing mode only afterthe first sensor detects user interaction with the medication pack. Inthis way, battery life of the medication compliance device can beextended, particularly when the second sensor is an audible, optical orother high energy usage sensor.

In a third aspect of the present invention, a medication adherencesystem communicates the sensing of user interaction with the medicationpack contained within the smart case via a network that may beaccessible by or share the sensed data with a third party such as ahealth care provider to whom the user has granted permission to receivesuch data. The medication adherence system may include an applicationserver which may reside in a mobile phone, or may reside in anycentralized server or computer that is accessible via a network. Theapplication server may contain a software application and a database.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an embodiment of the medication adherence system.

FIG. 2A depicts an embodiment of the smart case in a closed position.

FIG. 2B depicts an embodiment of the smart case in an open position.

FIG. 3 depicts an embodiment of the smart case in an open position witha medication pack removably attached and an additional pocket.

FIG. 4 depicts an embodiment of the smart case in an open positionwherein a medication pack is removably attached to a frame.

FIG. 5 depicts an embodiment of the smart case in an open position witha sliding open/close mechanism.

FIG. 6 illustrates an embodiment of the smart case in an exploded view.

FIG. 7 illustrates an exemplary set-up operation of the method forfacilitating compliance with a medication dosage schedule.

FIG. 8 illustrates an exemplary operation of the medication adherencesystem.

DETAILED DESCRIPTION OF THE INVENTION

Before the present systems and methods are described, it is to beunderstood that this disclosure is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present disclosure will be limited only by the appendedclaims.

As used herein, the terms medication and pill may be singular or plural,can be used interchangeably herein, and refer to any size or shape of asolid formulation that is prepared for oral administration such as apill, capsule, tablet, granule, and so forth. Furthermore, as usedherein, the terms medication and pill may refer to prescription as wellas over-the-counter medications as well as dietary supplements includingvitamins and minerals. Furthermore, the terms blister pack andmedication pack may be used interchangeably herein. In a preferredembodiment, the terms medication, medicine, and pill refer to aprescription contraceptive medication. In addition, the terms medicationand pill refer to any orally administered formulation which need to beused on a predetermined, scheduled basis.

A medication event, as used herein, may include, but is not limited to,the user interacting with their medication, the user accessing themedication pack from the smart case, the dispensing of medication from amedication pack or medication dose holder, or the user opening andclosing the case which contains the medication doses in the medicationdose holders.

The embodiments of the present invention are generally directed tosystems and methods for assistance in medication compliance in users orpatients who are undergoing prescription or over-the-counter medicationtherapy, and also for assistance to any user of dietary supplementsincluding vitamins and minerals.

In various embodiments, the present invention is directed toward amedication adherence system including a smart case, which is amedication compliance device, and a method for assisting a user orpatient in medication compliance and for facilitating adherence to amedication dosage schedule.

With reference to FIG. 1 , the medication adherence system 100 mayinclude an application server 101 which may reside in a mobile phone102, or may reside in any centralized server or computer that isaccessible via a network. In one example, the application server mayreside in a cloud server 103. The application server may contain asoftware application 104 and a database 105. The database 105 mayinclude such information as compliance data, prescription data, andanalytics on user behaviour.

The medication adherence system 100 may also include a sensor anddata-enabled smart case 200. The smart case 200 can be connected withthe application server 101 via Bluetooth 106, wi-fi 107, or another datatransmission modality. The application server 101 is preferablyconnected to a mobile phone 102 which can be defined as any mobile phonecapable of communicating with the smart case 200 and running thesoftware application 104. For example, the mobile phone 102 could be anApple iPhone, an Android phone, a Samsung Galaxy phone, or anothermobile device that has cellular network capability such as a 3G or 4Gversion of the Apple iPad or another tablet.

In various illustrative embodiments of the invention, the smart case200, as shown in FIG. 2A, includes a lid 601 and a base 611, and may bejoined by a hinge 202, as shown in FIG. 2B. The base includes areceptacle 207 which is configured to receive a plurality of medicationdose holders 303, such as individual blisters in a medication pack suchas a blister pack 301, each of which typically includes a single dose ofa medication, usually a pill, capsule, lozenge, or the like. Themedication dose holders 303 are configured so that a user can open oneat a time to access the medication dose therein, usually according to apredetermined dosing schedule, e.g. daily. The lid 601 and base 611 eachhave inner and outer surfaces and can be opened and closed. The lid maybe held closed by magnets 602 or other conventional latches. The lid andbase may be fabricated from any durable, lightweight material that issuitable to protect a plurality of medication doses from light,temperature, and other ambient influences. The smart case 200 dimensionswould be derived to accommodate a variety of medication packs 301. Forexample, the dimensions of a medication pack receptacle 207 (see FIG.2B) could range from a length of approximately 50-65 mm and a width ofapproximately 65-100 mm. The smart case, as shown in FIG. 3 , mayfurther include a compartment 302 for storing other materials andproducts, such as alternative birth control methods (condoms etc).

As shown in FIG. 4 , an embodiment of a smart case 400 includes a lid601 and base 611 as described previously and can be connected with ahinge 402 at their inner and/or outer surfaces. The hinge canaccommodate a frame 401 that is attached to the base for removablyreceiving a medication pack 301, whereby the attachment mechanism forthe frame 401 can be configured to comprise a spring hinge, and adaptedto urge the medication pack 301 which contains a plurality of medicationdoses, such as pills 303, forwards or upwards to facilitate dispensingof one or more medication doses.

In another embodiment of the present invention, a smart case 500, asshown in FIG. 5 , comprises a case lid 501 which slides open and closedover a case base 502 to expose the medication pack 301. Otherembodiments of the smart case can take the form of a sheath, sleeve,pill bottle, or any other form of container which can accept theplurality of medication dose holders and doses.

FIG. 6 shows an example of a smart case in an exploded view. The smartcase 200 contains at least one sensor that is operatively connected tothe circuit board 609 of the smart case 200 and can sense when the smartcase 200 is opened and closed. In one embodiment, this sensor is a HallEffect sensor 613 which functions based on a change in the magneticfield detected between a magnet 602 and steel bar 614 whichalternatively could also be a magnet. The magnet 602 is secured to thelid 601 of the smart case 200 via magnet covers 603. This sensor couldbe sufficient for detecting a medication event, especially when pairedwith a computer-aided algorithm which can determine the relevance of thesignal from each sensor.

Alternatively, the signal detection by a sensor such as the Hall Effectsensor 613 could trigger a secondary set of sensors which detect thestatus of the blister pack 301 in the smart case 200. In the oneembodiment, this is achieved by an inductive sensor 608 which can detectwhen the blister pack 301 is removed from the smart case 200.Alternatively, this could be achieved by infrared (IR) sensors 615 whichcan monitor the presence or absence of individual medication doses 303or the medication pack 301 through the IR window 605. Audio data couldalso be monitored and collected through an audio port 205 on the smartcase 200. The duration and quality of any of the signals sensed by thesmart case can be interpreted and analyzed as a potential medicationevent.

The electrical activity is supported by a power unit 606. The data istransmitted via low energy Bluetooth 106 to the software application104, and can also be stored and processed in a chip on the circuit board609. The pairing between the software application 104 and the smart case200 can be triggered by a switch, which is activated by the user bydepressing the button 607 relative to the midframe 604 of the smart case200.

The smart case 200 can utilize a variety of sensors for detectingopening and/or closing of the lid 601 or 501 and for removing individualmedication doses 303 on a medication pack 301. A presence sensor, e.g.,an optical, pressure or conductivity sensor, detects the presence orabsence of, e.g., a medication dose, by detecting the electricalcontinuity or discontinuity between two sensors. Electromechanicalsensors sense a change in magnetic or solid state electronic fields.Audio sensors, such as microphones, are able to detect sounds producedby or near the medication adherence system, e.g. by opening or closingthe lid 601, by removing individual medication doses 303, etc. Sensorsinside and/or outside of the smart case can track ambient conditionssuch as temperature, humidity, ambient light.

The smart case 200 may also have a light-emitting diode (LED), which isviewed by the user through a light pipe 610. Multi-color or single colorLEDs may be used to convey information to users in accordance to color.For example, the light source may turn red when a user is overdue intaking a medication dose, and the medication is a contraceptive pill,and as a consequence the user is at a heightened risk of pregnancy. Thelight source may turn green when the medication dose was taken inaccordance to the indicated or recommended dosage schedule, and as aconsequence the user faces no or only a low risk of pregnancy. The lightsource may turn yellow when the medication dose was taken later thanindicated by the dosage schedule, and as a consequence the user is at amedium risk of pregnancy. The light source may turn blue when a networkconnection is established and information is received and/ortransmitted. The light sources may be piped around the surfaces of thesmart case and therefore be visible from all sides; or it may be aone-sided light pipe 203, as shown in FIG. 2A. The circuit board 609 issecured in the smart case 200 between the base 611 and a midframe 604,as shown in FIG. 6 . Such a subassembly may be attached to the lid 601of the smart case 200.

FIG. 7 illustrates an exemplary set-up operation of the method forfacilitating compliance with a medication dosage schedule within themedication adherence system. At a step 701 a user 108 will download thesoftware application 104 to their mobile phone 102. At a step 702 theuser 108 can pair the smart case 200 with the software application 104by entering pairing mode on the software application 104. The activationof a switch on the smart case 200 (for example, by depressing the button206) puts the smart case 200 in pairing mode. At a step 703, once pairedvia Bluetooth 106, for example, the connection between the smart case200 and software application 104 is maintained. The smart case 200 maybe received by the user 108 with a medication pack 301 already stored init, or, at a step 704, the user 108 may place the medication pack 301into the smart case 200. At a step 705, at the beginning of each newcycle, the user 108 places a new medication pack 301 into the smart case200.

FIG. 8 illustrates an exemplary operation of the medication adherencesystem. The diagram illustrates exemplary event detections and datatransmissions for monitoring a user's interactions with the smart case,facilitating dose reminders, logging the compliance status, andproviding instructions such as indicating the current risk of pregnancyand steps to take in order to avoid pregnancy such as using alternativecontraceptive methods, if the medication is a contraceptive pill. At astep 801, the sensors on the smart case 200 detect when the smart case200 is opened and may detect when the medication pack 301 is removedfrom the smart case 200 and/or an individual medication dose holder 303is opened and/or the individual medication dose is removed andpresumably consumed. At a step 802, sensing data will be transmitteduntil a step 803 in which the data is received by the softwareapplication 104 on the mobile phone 102. The sensing data may be storedon a local processor on the smart case 200 until the case is withinrange of the mobile phone 102.

At a step 804, the mobile phone 102 software application 104 monitorsthe data that it receives from the smart case 200 relative to theindicated or recommended dosage schedule, i.e., the time on each daywhen the user 108 is expected or due to take one or more medicationdoses. At a step 805, a missed dose is noticed by the mobile phone 102software application 104 as indicated by an absence of data sent fromthe smart case 200. At a step 806, the current time is compared to a“medication window”, i.e. the time window during which the user 108 issupposed to take one or more medication doses 303. The mobile phone 102software application 104 accounts for time zone changes when the user108 is traveling to accurately make this assessment. At a step 807, ifthe current time is before the medication window, the medicationadherence system 100 continues to passively monitor. At a step 808, thecurrent time is evaluated to be past the medication window. In thiscase, at a step 809 the mobile phone 102 software application 104prompts the user 108 with a reminder, for example via a SMS textmessage, local notification, or push notification. The softwareapplication 104 continues to send reminders until the user 108 consumesone or more medication doses 303 as indicated by the appropriatemedication dosage schedule. At a step 810, the software application 104categorizes the data it receives from the smart case 200 to determine ifthe medication dose was taken early, on time, late, or if the medicationwindow was entirely missed. At a step 811, this information isinterpreted in order to provide the user 108 with clear and relevantinstructions for how to properly use the medication and, e.g., reducepregnancy risk. At a step 812, this data can be uploaded to the cloud903. At a step 813, this database 105 can be shared with an authorizeduser such as a pharmacy or other health care provider, who can use theinformation to provide informed recommendations to the user 108 onmedication selection and management if a medication dose was missed.

Motion sensors data can be generated by a sensor attached to the lid 601and/or base 611 of the smart case 200, as shown in FIG. 6 . The datacollected by the motion sensor can indicate when the smart case 200 ismoved, a lid 601 is opened, when the frame 401 is pushed up or down, andany other movements including vibrations or a change in pressure resultsthat may occur when a medication dose 303 is dispensed from the smartcase 200. For example, the hinge 202 can accommodate a sensor that isconfigured to sense the opening and/or closing (motion) of the lid 601or base 611. The motion data can be analysed to determine whether itmatches with a distinctive movement pattern that is associated withdispensing a medication dose and whether, in accordance with themovement pattern, a medication was likely dispensed from the smart case200.

In some embodiments, the case may generate a wireless signal via wi-fi107, Bluetooth 106, or Bluetooth 106 low energy to send the sensor datato the application server 101. For users 108 who are mobile with thesmart case 200, low energy Bluetooth is the preferred embodiment.

The medication adherence system may further comprise a power unit 606.Power to the smart case 200 and the medication adherence system 100 isprovided by either a battery or a power supply module which connects toan outside power source. Power can, e.g., be provided through a standarduniversal serial bus (USB) port. Additionally or alternatively, otherports may be used that support proprietary connectors, micro-USB, SATAcables, Lightning, etc.

The software application 104 can be programmed with an algorithm totrack a user's medication compliance, i.e. adherence to a medicationdosage schedule, by comparing the most recent medication dispensingevent, such as opening of the case, to a pre-programmed “ideal” scheduleof medication dispensing events. Alarms, reminders and other feedbackcan then be provided using a visual output, auditory output or tactileoutput to alert the user to proceed with a medication dispensing eventor to provide the user with instructions what else to do, if amedication dose was missed. The smart case 200 may generate a signalsuch as light, voice, vibration, or a combination thereof, to assist theuser in adhering to a medication dosage schedule. The signal may begenerated in predefined, periodic time increments or intervals, or mayonly be generated if a medication dose was not dispensed as scheduled.

Additionally, indicators may be present on the smart case to prompt theuser to initiate a medication event, or to indicate that a medicationevent has occurred. Indicators that may be included on the smart casecan comprise visual indicators (e.g. LED light and/or array,electroluminescent display, electronic paper, color changing components,etc.), olfactory indicators, and tactile indicators (e.g. vibration,raised features). For example, a visual indicator may communicate thetime and location of the most recent medication event, or the medicationwindow for the next medication event.

The medication adherence system may further comprise a communicationmodule configured to permit communication with an external smart devicesuch as mobile phones, smart phones, tables, portable media devices,wearable devices, laptops, servers using a data transmission protocolsuch as RFID, Bluetooth, NFC, sigFox, qual2 or similar. The externaldevice may include a piece of software, e.g. a mobile application, thatcan receive and process sensor data, and generate a user interface forvarious users to share the sensor data and/or its interpretation.

The external device can be used to display reminders, compliancesummaries or other information such as advice on what to do if amedication event was missed. In another embodiment, the smart case isconfigured to permit wireless or wired communication to a health networkor medical professional in accordance to the user's pre-recordedinstructions.

The connection allows information, e.g. sensor data, recorded by theelectronic display, user input, and sensors, e.g. audio sensor/motionsensor/lid sensor/pressure sensor, to be transmitted electronicallyacross a network. One or more networks can be used to communicativelycouple the various components of the medication adherence system. Anetwork connection can also be established with physicians, pharmacistsand other providers to share the sensed data with.

Generally, the communication module establishes a wired or wirelessconnection between the case and other computing devices. For example,the information may be transmitted via wireless connection, if anyantenna technology is supported such as Bluetooth, Bluetooth Low Energy(BLE), cellular (3G, 4G, etc.), Near Field Communication (NFC), wirelesslocal area network (WLAN) transmitters, Infrared, V-2-V communication,radiofrequency (RF), and other wireless technologies. The informationmay also be transmitted via wired connection using, e.g., a USB ormini-USB port.

The communication module can be housed within an electronics modulecompartment which may also house additional modules and/or componentssuch as processors, communication devices, integrated electronics,memory storage devices, batteries, sensors.

For oral contraceptives used for birth control, there is often apredetermined dosing regimen for how to proceed if an oral contraceptivepill is missed. This predetermined dosing schedule is based on what timethe pill 303 was missed in the medication dosing window (e.g. @7 PM vs.5 PM—2 hours later than daily dosing window), when the pill was missedin the overall cycle (e.g. day 7 of a 28 day cycle), what type of birthcontrol a user is prescribed (e.g. combined hormonal, or progesteroneonly), and other factors. In some embodiments, smart case 200 will havethe ability to display different stimuli to the user to communicatedifferent treatment recommendations (e.g. via various LEDconfigurations).

Medication events may be recorded via a number of different means. Inone embodiment, a latching mechanism on the smart case 200 can recordwhen the latch is opened or closed, such as via an electrical switchingmechanism (e.g. circuit completed or broken when case is opened/closed),a mechanical mechanism (e.g. a sensor is depressed when the smart caseis closed only when a medication pack is present within the case), apiezo electric mechanism, or an optical mechanism. In anotherembodiment, pressure from the case closing is recorded by a sensor (e.g.pressure sensitive transducer) in the smart case 200. There may anindicator (e.g., LED light and/or array, electroluminescent display,electronic paper) on the smart case 200 to prompt the user to initiate amedication event. There may also be an indicator (e.g., light and/orarray, electroluminescent display, electronic paper) on the smart case200 to prompt the user with instructions regarding which specificmedication to take, how many medication doses to take, or otherinformation related to the medication dosage schedule. The smart casecan additionally or alternatively include an auditory feedback, tactilefeedback, or any other type of interface configured to provide aperceptible reminder and/or feedback to the user to consume a medicationdose or to alert the user if a scheduled dose was missed.

In one embodiment, the strength of the feedback increases as the timeand/or geographical location of the standard medication dosing windowdraws closer. For example, in one embodiment the smart case 200 can bepaired with a mobile phone 102 to detect proximity of the user 108, andif a pre-defined degree of proximity was detected within or after thestandard, i.e. recommended, medication dosing window, the feedback onthe medication adherence system 100 would automatically engage toattempt to alert the user 108. The medication adherence system 100 mayalso have the functionality to not engage the feedback within thestandard medication dosing window if the user 108 is not within apre-defined degree of proximity. Other embodiments can have differentmethods for how to engage the user with feedback or stimuli based ondosing schedule, geographical location, and other important features.

The medication adherence system 100 includes a wireless communicationmodule to transmit a medication event to the software application 104wirelessly paired to the smart case 100, or to a wireless communicationhub. If the medication adherence system 100 is unable to establish awireless connection, the smart case 200 can store information regardingmedication events in memory until a wireless connection is established.The smart case 200 may also include, but is not limited to, an internalclock, an accelerometer/gyroscope, and/or a GPS module to saveadditional relevant information related to the medication event. In oneembodiment, the smart case 200 can use power from a local battery sourceto initiate a connection with a mobile phone 102 or wirelesscommunication hub, and thereafter enter a “sleep” mode where the localcomputing device then powers the smart case 200 via direct or indirectmeans (e.g. inductive coupling) to extend the battery life of theaforementioned smart case 200.

In an alternative embodiment of the smart case 200, the dimensions ofthe case can be configured to match different shapes and sizes ofmedication packs 301, such as circular birth control packs.

In one embodiment, the smart case 200 may take the form of an outersheath with a surface that receives a medication pack 301 that slides inand out of the sheath. The smart case detects when a medication dose isremoved by detecting the location at which a medication dose and/or themedication pack crossed the threshold of the smart case (e.g. a grid).The sensors for detecting a medication event may include optical,electrical, mechanical, electromagnetic, capacitive, resistive, or piezoelectric means. Sensors may be integrated together to improve thepredictive accuracy of the medication adherence system, e.g. only eventsare recorded where large force is generated via piezo electrictransducer, and optical coupling is interrupted by the rupture of amedication dose holder.

The description and specific examples herein are intended for purposesof illustration only and are not intended to limit the scope of thepresent disclosure. Therefore, the scope of the appended claims shouldnot be limited by the specific examples set forth, but should be giventhe broadest interpretation consistent with the description as a whole.

What is claimed is:
 1. A medication compliance case for receiving amedication pack having a plurality of medication dose holders andwirelessly communicating with an external device, said case comprising:a base for removably receiving the medication pack; a lid attached tothe base and having a closed position where the medication pack iscovered and open position; a lid sensor configured to detect when thelid is moved between the closed position and the open position; amedication pack sensor on the base configured to detect when themedication pack is removed from the medication compliance case;circuitry comprising a processor and a wireless link, wherein the lidsensor and the medication pack sensor are connected to the circuitry andthe circuitry is configured to (a) emit a signal via the wireless linkto the external device when the medication pack sensor detects removalof the medication pack from the base and (b) to power the medicationpack sensor only when the lid sensor indicates that the lid is in theopen position; and a power source connected to the circuitry.
 2. Amedication compliance case as in claim 1, further comprising a latch,wherein said lid sensor comprises a latch sensor configured to detect atleast one of opening and closing of the latch.
 3. A medicationcompliance case as in claim 2, wherein the latch sensor comprises acapacitive, resistive, electromagnetic, piezoelectric, optical,inductive, mechanical, electromechanical, acoustic, or image processingsensor.
 4. A medication compliance case as in claim 2, wherein the latchcomprises a metal element on the lid and a metal element on the base,wherein at least one of the metal element on the base and the metalelement on the lid is magnetic, and wherein the latch sensor comprises aHall Effect sensor configured to detect at least one of opening andclosing of the at least one magnetic metal element of the latchmechanism.
 5. A medication compliance case as in claim 1, wherein themedication pack sensor comprises a capacitive, resistive,electromagnetic, piezoelectric, optical, inductive, mechanical,electromechanical, acoustic, or image processing sensor.
 6. A medicationcompliance case as in claim 1, wherein the lid is attached to the baseby a hinge.
 7. A medication compliance case as in claim 1, wherein thelid is slidably attached to the base.
 8. A medication compliance case asin claim 1, further comprising a dose holder sensor which detectsopening of a single dose holder, wherein the dose holder sensor isconnected to the circuitry and the circuitry is configured to emit asignal via the wireless link to the external device each time a doseholder is opened.
 9. A medication compliance case as in claim 8, whereinthe dose holder sensor comprises a capacitive, resistive,electromagnetic, piezoelectric, optical, inductive, mechanical,electromechanical, acoustic, or image processing sensor.
 10. Amedication compliance case as in claim 1, further comprising a frameattached to the base for removably receiving the medication pack.
 11. Amedication compliance case as in claim 10, wherein the frame is attachedto the base by an attachment mechanism that raises the frame andmedication pack above an upper surface of the base when the lid isopened.
 12. A medication compliance case as in claim 11, wherein theattachment mechanism comprises a spring hinge.
 13. A method forfacilitating compliance with a medication dosage schedule, the methodcomprising: providing a medication compliance case according to claim 2,said medication compliance case holding a medication pack comprising aplurality of individual medication dose holders; sensing, with the lidsensor when a user has opened the lid to gain access to individualmedication dose holders on the medication pack; sensing with themedication pack sensor when the medication pack is removed from themedication compliance case, wherein the medication pack sensor isenergized only when the lid sensor has sensed that the user has openedthe lid; and emitting a signal to the external device via the wirelesslink when the medication pack sensor detects removal of the medicationpack from the base.
 14. A medication compliance case for receiving amedication pack having a plurality of medication dose holders andwirelessly communicating with an external device, said case comprising:a base having an opening and an interior for removably receiving themedication pack; a latch for opening and closing the opening to theinterior; a latch sensor configured to detect at least one of openingand closing of the latch a medication pack sensor configured to detectwhen the medication pack is removed from the medication compliance case;circuitry comprising a processor and a wireless link, wherein the latchsensor is connected to the circuitry and the circuitry is configured topower the medication pack sensor when the latch is opened to emit asignal via the wireless link to the external device when the medicationpack sensor detects removal of the medication pack from the base; and apower source connected to the circuitry.
 15. A medication compliancecase as in claim 14, wherein the latch sensor comprises a capacitive,resistive, electromagnetic, piezoelectric, optical, inductive,mechanical, electromechanical, acoustic, or image processing sensor. 16.A medication compliance case as in claim 14, wherein the latch comprisestwo metal elements, wherein at least one of the metal elements ismagnetic and the latch sensor comprises a Hall Effect sensor configuredto detect at least one of opening and closing of the at least onemagnetic metal element of the latch mechanism.